Quantitative immunoassays such as ligand binding assays for toxicokinetic and pharmacokinetic studies supporting biologic preclinical and clinical development
Quantitative immunoassays are used to measure the amount of biologics therapeutic products in a biologic matrix, such as plasma or serum. Immunoassays are based on the specific binding ability of an antibody and are used to determine the safety and efficacy of biopharmaceuticals through toxicokinetic (TK) and clinical pharmacokinetic (PK) support services for therapeutic macromolecules.
Quantitative immunoassay such as ligand binding assays can be difficult to develop and validate. Their unique challenges include establishing method selectivity, specificity and range of quantitation as a result of nonspecific background signal, matrix interference, lack of linearity (prozone/hook effect) and antibody interference. Selection of the appropriate assay format and purity/quality of reagents are also critical for robust and reliable data.
Our capabilities for quantitative immunoassays include developing methods for biologics and biosimilars, method transfer, optimization and validation of existing methods (including kit assays) suitable for use in TK and PK studies. Utilizing a variety of detection platforms, including enzyme-linked immunosorbent assay (ELISA) and electrochemiluminescence (ECL), we follow Good Laboratory Practice (GLP) guidelines to provide accurate test results and verifiable, reproducible data that can assist you in compressing timelines whilst meeting the requirements for the drug approval process.
With proactive teams who are accountable for assay development, validation guidelines, data integrity and client communication, new projects are assigned and managed by a Principal Investigator (PI) with support from a team of experienced analysts and a Project Coordinator. Our scientists ensure that methods are developed, and validated within the desired timelines, samples are securely accessioned and analysed accurately with quality control steps to ensure the accuracy of raw data and data tables. Final auditing, checking of data and reporting is performed by the Quality Assurance Unit.
Intertek can also provide comprehensive characterisation services for critical reagents such as antibodies. Our team of experienced analytical scientists can determine the structural and physico-chemical properties and biologic activity of these reagents to ensure quality and can use the data to explore batch to batch variation.
With an unrivalled depth and breadth of bioanalytical expertise, we can address even your most challenging immunoassay requirements. We anticipate all sources of risks related to the development, validation or ongoing use of an immunoassay so that you obtain the data you need to make decisions during preclinical and clinical development. Our experts have worked with thousands of biologics to support our global clients with collaborative technical solutions so you can trust in us to help accelerate timelines, assist you to meet critical milestones and provide Total Quality Assurance.